Draft Guidance for Industry; Submission of Documentation in Drug Applications for Container Closure Systems Used for the Packaging of Human Drugs and Biologics; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D-0268]

Draft Guidance for Industry; Submission of Documentation in Drug

Applications for Container Closure Systems Used for the Packaging of

Human Drugs and Biologics; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability of a draft guidance entitled ``Guidance for Industry:

Submission of Documentation in Drug Applications for Container Closure

Systems Used for the Packaging of Human Drugs and Biologics.'' This

draft guidance was prepared by FDA's Center for Drug Evaluation and

Research (CDER) and the Center for Biologics Evaluation and Research

(CBER). The draft guidance discusses information on container closure

systems used in packaging drugs that manufacturers should provide to

CDER in meeting regulatory requirements for new drug applications

(NDA's), abbreviated new drug applications (ANDA's), investigational

new drug applications (IND's), abbreviated antibiotic applications

(AADA's), and supplements to these applications, and to CBER in meeting

requirements for biologics license applications (BLA's) and product

license applications (PLA's). The draft guidance, when completed, will

supersede the agency's ``Guideline for Submitting Documentation for

Packaging for Human Drugs and Biologics,'' issued February 1987. The

agency requests comments on the draft guidance.

DATE: Written comments by September 15, 1997. General comments on

agency guidance documents are welcomed at any time.

ADDRESSES: Submit written requests for single copies of the draft

guidance entitled ``Guidance for Industry: Submission of Documentation

in Drug Applications for Container Closure Systems Used for the

Packaging of Human Drugs and Biologics'' to the Drug Information Branch

(HFD-210), Center for Drug Evaluation and Research, Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-

addressed adhesive label to assist that office in processing your

request. Submit written comments on the draft guidance to the Dockets

Management Branch (HFA-305), Food and Drug Administration, 12420

Parklawn Dr., rm. 1-23, Rockville, MD 20857. Requests and comments

should be identified with the docket number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT: Alan C. Schroeder, Center for Drug

Evaluation and Research (HFD-570), 5600 Fishers Lane, Rockville MD

20857, 301-827-1050.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a

draft guidance entitled ``Guidance for Industry: Submission of

Documentation in Drug Applications for Container Closure Systems Used

for Packaging of Human Drugs and Biologics.'' The guidance discusses

information on container closure systems used in packaging drugs that

manufacturers should provide to CDER and CBER in meeting regulatory

requirements for initial applications, amendments, and supplements.

The Federal Food, Drug, and Cosmetic Act (the act) authorizes FDA

to establish standards for drug product packaging, including containers

and closures. According to section 501(a)(3) of the act (21 U.S.C.

351(a)(3)), a drug is deemed to be adulterated if its container is

composed, in whole or part, of any poisonous or deleterious substance

which may render the contents injurious to health * * *. Under section

505(b)(1)(D) of the act (21 U.S.C. 355(b)(1)(D)), an application for

approval to market a new drug must include ``a full description of the

methods used in, and the facilities and controls used for, the

manufacture, processing, and packing of such drug.'' FDA's regulations

on current good manufacturing practices for the control of drug product

containers and closures are set forth in subpart E of part 211 (21 CFR

part 211). In particular, Sec. 211.94 states that finished drug

manufacturers must establish and follow ``[s]tandards or

specifications, methods of testing, and, where indicated, methods of

cleaning, sterilizing, and processing to remove pyrogenic properties *

* * for drug product containers and closures.''

In February 1987, FDA issued a ``Guideline for Submitting

Documentation for Packaging for Human Drugs and Biologics.'' The

guideline was intended to provide drug manufacturers with guidance on

preparing information on the fabrication and quality of containers and

container components for use in the submission of NDA's, ANDA's, IND's,

or PLA's.

The draft ``Guidance for Industry: Submission of Documentation in

Drug Applications for Container Closure Systems Used for Packaging of

Human Drugs and Biologics'' revises and updates the February 1987

guideline to reflect innovations in drug product container closure

systems that have occurred in the past decade. In addition, the

document provides more extensive guidance on qualification and quality

control of packaging components used with drug products having

particular dosage forms and routes of administration, including the

following: Inhalation drug products, drug products for injection and

ophthalmic drug products, liquid-based oral and topical drug products

and topical delivery systems, solid oral dosage forms and powders for

reconstitution, and other dosage forms. The draft guidance also

addresses post-approval packaging changes, Type III drug master files,

and bulk containers. The draft guidance, when completed, will supersede

the 1987 guideline.

This draft guidance represents the agency's current thinking on

submitting information in drug applications on container closure

systems used in packaging human drugs and biologics. It does not create

or confer any rights for or on any person and does not operate to bind

FDA or the public. A regulated entity may adopt an alternative approach

to submitting information on container closure systems if such approach

satisfies the applicable statutory and regulatory requirements.

Interested persons may, on or before September 15, 1997, submit to

the Dockets Management Branch (address above) written comments on the

draft guidance. Two copies of any comments should be submitted, except

that individuals may submit one copy. Comments are to be identified

with the docket number found in brackets in

the heading of this document. The draft guidance and received comments

may be seen in the office above between 9 a.m. and 4 p.m., Monday

through Friday. An electronic version of this draft guidance is

available via Internet using the World Wide Web (WWW) at http://

www.fda.gov/cder/guidance.htm.

[[Page 37926]]

Dated: July 6, 1997.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 97-18460 Filed 7-14-97; 8:45 am]

BILLING CODE 4160-01-F